Index Ventures

Position Purpose

This person will be required to assess internal quality and efficiency of Drug Safety and Pharmacovigilance operations on an ongoing basis and develop and implement procedures and measures to ensure the highest quality, accuracy and timelines of departmental output. This position will provide oversight and direction to third-party vendors in establishing and maintaining effective processes in ensuring appropriate handling and reporting of serious adverse events reported from sponsored clinical trials. This person will represent Drug Safety on Project Teams and will implement operational strategies to meet the requirements of corporate collaborations and to support post-marketing surveillance activities associated with market launch of newly approved products.



Duties and Responsibilities

· Lead in the development and maintenance of efficient and effective company Drug Safety/ Pharmacovigilance systems, processes, and procedures to increase monitoring and reporting capability in a clinical development and post-marketing surveillance context and ensure compliance with U.S. and international Drug Safety reporting requirements and regulations

· Perform initial and ongoing evaluation of third-party PVG vendors and provide oversight and direction in day-to-day operations involving vendors

· Develop or oversee the development and maintenance of written and effective Safety Plans between ARIAD and 3rd party vendors

· Manage the day-to-day operations within Drug Safety and PVG by designing, planning and monitoring work strategies

Represent Drug Safety and Pharmacovigilance on cross-functional study teams and contribute to the generation and review of key clinical and regulatory documents including protocols, IBs, CRFs, ICFs, CSRs, INDs, Annual Report, etc
Provide strategic and operational input on potential partner agreements

Key Skills and Attributes:

Requirements:
Bachelor’s level degree in life sciences, pharmacy, nursing, or RN, or equivalent health experience
Minimum of 5 years experience in Drug Safety /Pharmacovigilance role in pharmaceutical industry
Demonstrated ability to create, evaluate, and maintain effective business processes and implement procedures, systems, and tools to maximize resources within a Drug Safety department
Thorough knowledge and experience in all aspects of safety reporting for clinical studies including MedDRA coding, EU Clinical Trial Directive, FDA and ex-US safety reporting regulations, ICH, signaling and general Pharmacovigilance Principles
Ability to successfully prioritize and work on multiple tasks
Effective verbal and written communication skills; must have demonstrated ability to write business processes in a clear, concise and accurate manner
Strong interpersonal skills and demonstrated ability to manage, motivate and influence work behaviors of individuals who are not direct reports
Prior supervisor experience is desired

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